FDA.reportPublic FDA data

ibuprofen

Product NDC
42507-647
11-digit product format
425070647
Labeler code
42507
Product ID
42507-647_540e3bdd-bc24-4016-a8e3-ef9d0af384ea
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
HyVee Inc
Application
ANDA072096
Marketing category
ANDA
Marketing start
1989-07-15
Substance
IBUPROFEN
Active strength
200 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ibuprofen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui310965

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42507-647-00ibuprofen100 in 1 BOTTLETABLET, FILM COATED1005
42507-647-50ibuprofen50 in 1 BOTTLETABLET, FILM COATED505
42507-647-62ibuprofen1 in 1 CARTONTABLET, FILM COATED15
42507-647-62ibuprofen24 in 1 BOTTLETABLET, FILM COATED245
42507-647-71ibuprofen1 in 1 CARTONTABLET, FILM COATED15
42507-647-76ibuprofen120 in 1 BOTTLETABLET, FILM COATED1205
42507-647-76ibuprofen1 in 1 CARTONTABLET, FILM COATED15
42507-647-78ibuprofen1 in 1 CARTONTABLET, FILM COATED15
42507-647-90ibuprofen500 in 1 BOTTLETABLET, FILM COATED5005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN4c24c884-55f7-40b4-8d6f-db6144d5ebcb5
310965ibuprofen 200 MG Oral TabletSCD4c24c884-55f7-40b4-8d6f-db6144d5ebcb5
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY4c24c884-55f7-40b4-8d6f-db6144d5ebcb5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42507-647-0042507064700100 in 1 BOTTLEHistorical
42507-647-504250706475050 in 1 BOTTLEHistorical
42507-647-62425070647621 BOTTLE in 1 CARTON (42507-647-62) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle1989-07-15NoNoCurrent
42507-647-71425070647711 BOTTLE in 1 CARTON (42507-647-71) / 50 TABLET, FILM COATED in 1 BOTTLE (42507-647-50) 1 bottle1989-07-15NoNoCurrent
42507-647-7642507064776120 in 1 BOTTLEHistorical
42507-647-78425070647781 BOTTLE in 1 CARTON (42507-647-78) / 100 TABLET, FILM COATED in 1 BOTTLE (42507-647-00) 1 bottle1989-07-15NoNoCurrent
42507-647-9042507064790500 TABLET, FILM COATED in 1 BOTTLE (42507-647-90) 1989-07-15NoNoCurrent